Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C

Hepatitis C Clinical Trial

Official title:

New AbbVie Direct Acting Antiviral (DAA) Treatment of Chronic Hepatitis C Infection - Effects on the Macrophage Activation Marker Soluble CD163, Portal Hypertension, and Metabolic Liver Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526641
• Other study ID #: HCV sCD163 AbbVie
• Status: Completed
• Start date: August 2015
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)

• Child-Pugh A liver cirrhosis

Exclusion Criteria:

• Severe liver dysfunction - Child-Pugh klasse B-C

• Life expectancy less than 6 months

• planned liver transplantation or TIPS procedure within 6 months

• non-compliance to treatment or study procedures

• allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)

• pregnancy or expected pregnancy during the study (anti-conception has to be used)

• breast feeding

• portal vein thrombosis

• liver cancer or other malignancies

• alcohol consumption

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hypertension
• Hypertension, Portal

Intervention

Procedure:
• Functional Hepatic Nitrogen Clearance (FHNC)

• Galactose Elimination Capacity (GEC)

• Liver vein catheterization

Locations

Country	Name	City	State
Denmark	Department of Hepatology and Gastroenterology, Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, AbbVie

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks		12 weeks
Primary	Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year		1 year
Secondary	Changes in the levels of the macrophage specific activation marker sCD163		Before, during and after treatment - 60 weeks
Secondary	Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test		After 12 weeks treatment
Secondary	Changes in the functional hepatic nitrogen clearance (FHNC)		After 12 weeks treatment